The team is joined by Guest Kats Rosie Burbidge, Stephen Jones, Mathilde Pavis, and Eibhlin Vardy, and by InternKats Verónica Rodríguez Arguijo, Hayleigh Bosher, Tian Lu and Cecilia Sbrolli.

Wednesday, 12 July 2017

An improved Improver? UK Supreme Court moves towards a UK Doctrine of Equivalents in Lilly pemetrexed battle

It is here - the Supreme Court's decision in Eli Lilly v Actavis UK [2017] UKSC 48.  This is an important case about whether drugs manufactured by Actavis infringe a European patent of Lilly. The product in question is pemetrexed
which is an anti-cancer drug, damaging side-effects of which can be mitigated if it is given together with vitamin B12. The case reviews some fundamental aspects of patent law as applied in the UK and Europe including with regard to "equivalents", and the scope and applicability of "purposive construction" and the so-called Improver questions.
Eli Lilly has been marketing pemetrexed with vitamin B12,
 under the brand name Alimta, since 2004


The patent claims the use of the disodium salt of pemetrexed in the manufacture of a medicament for use in combination with vitamin B12 for the treatment of cancer. The dispute between the parties which came before the Supreme Court boiled down to whether a medicine containing a different salt of pemetrexed would infringe the patent, either directly or indirectly. The Patents Court (Arnold J. [2015] RPC 6) had decided that none of the Actavis products would directly or indirectly infringe the patent. The Court of Appeal ([2015] EWCA Civ 555 and 556) allowed Lilly’s appeal in part holding that there would be indirect infringement, but not direct infringement. Lilly therefore appealed to the Supreme Court on the issue of direct infringement, and Actavis cross-appealed on indirect infringement.
  
Last week on 7 July the Supreme Court announced that it had allowed Eli Lilly’s appeal and held that Actavis’s products directly infringe Eli Lilly’s patent, as previously reported in IPKat. Today the court handed down its reasons for those conclusions, the unanimous decision being given by its President, Lord Neuberger, and the other Supreme Court justices, Lords Mance, Clarke, Sumption and Hodge, agreeing with it. The case deals with some important issues relating to patent infringement - including how alleged “equivalents” should be dealt with, whether the prosecution history of a patent should be used when interpreting its claims, and the scope of the concept of contributory or indirect infringement.

The court summarised the issues on direct infringement like this. Lilly said that the Actavis products infringe the Patent because they consist of a pemetrexed salt or the free acid with vitamin B12, which represents the essence of the teaching and claim of the Patent. Actavis said that they don't infringe because Lilly's claims are limited to a specific pemetrexed salt, pemetrexed disodium, and the Actavis products contain either the free acid or different pemetrexed salts such as the dipotassium salt.
Lord Neuberger
In construing the claim, the court was satisfied that "as a matter of ordinary language" the claims only extended to the disodium salt; but that was not the end of the story. The Protocol on the Interpretation of Article 69 as amended in EPC 2000 had to be factored in. The definition of infringement in section 60(1) of the Patents Act 1977 is, according to section 130(7) of the same Act, deemed to be “so framed as to have, as nearly as practicable, the same effects in the United Kingdom as the corresponding provisions of the European Patent Convention ...". Accordingly, the court had to look at the matter by reference to the EPC, including the effect of its amendment by EPC 2000. The relevant bit of the Protocol to Art. 69 is the new Art. 2 added by EPC 2000 which says "For the purpose of determining the extent of protection conferred by a European patent, due account shall be taken of any element which is equivalent to an element specified in the claims." That led the court to a consideration of prior English case law as well of that of other EPC member states. In doing so it acknowledged that the addition of Art. 2 had all the hallmarks of a compromise about it, and that “complete consistency of approach” between different national courts of the EPC states “is not a feasible or realistic possibility at the moment”, but nonetheless “it is sensible for national courts at least to learn from each other and to seek to move towards, rather than away from, each other’s approaches”, quoting from its own judgment in Schütz v Werit [2013] RPC 16.

In particular the court considered the evolution of the approach to equivalents in the UK, based on "purposive construction" of the claims, starting from from the decision of Lord Diplock in Catnic v Hill & Smith [1982] RPC 183 and moving through the questions originally posed by Lord Hoffmann in Improver v Remington [1990] FSR 181 which became known as the "Improver" or "Protocol" questions. Later, in Kirin-Amgen v Hoechst Marion Roussel [2005] RPC 9 Lord Hoffmann confirmed that purposive construction as in Catnic and Improver gave “effect to the requirements of the Protocol” and was “the bedrock of patent construction, universally applicable”, whereas the Protocol or Improver questions were simply “guidelines for applying that principle to equivalents ... , more useful in some cases than in others”.

Having gone through the case law in the UK and other EPC countries in some detail, the court went on to explain its own view, based on recognising that any patent system must strike a balance between the two competing factors referred to at the end of Article 1 of the Protocol, namely “a fair protection for the patent proprietor [and] a reasonable degree of legal certainty for third parties”. On that basis the court said that infringement is best approached by addressing two issues, each of which is to be considered through the eyes of the notional addressee of the patent, who is the person skilled in the art:
(i) does the variant infringe any of the claims as a matter of normal interpretation; and, if not,

(ii) does the variant nonetheless infringe because it varies from the invention in a way or ways which is or are immaterial?
If the answer to either issue is “yes”, there is an infringement; otherwise, there is not. The court said that this approach complies with article 2 of the Protocol, as issue (ii) "squarely raises the principle of equivalents, but limits its ambit to those variants which contain immaterial variations from the invention". Considered in that way, the court considered that question (i) raises a question of interpretation, whereas question (ii) would normally have to be answered by reference to the facts and expert evidence. The court then criticised Lord Hoffmann's "conflating" of these two issues in Kirin-Amgen as "wrong in principle".

In the court's view, issue (ii) involves not merely identifying what the words of a claim mean, but whether the the scope of protection should extend beyond that meaning - quoting Sir Hugh Laddie in "Kirin-Amgen - The End of Equivalents in England?" (2009) 40 IIC 3, para 68, “[t]he Protocol is not concerned with the rules of construction of claims” but with “determining the scope of protection”.

Applying question (i), there was no doubt that the Actavis products do not infringe, because the free acid or other salts of pemetrexed do not to fall within the expression, “pemetrexed disodium” in claim 1 of the Patent, any more than a slotted rubber rod could be said to be within the expression “a helical metal spring” in the claim in the Improver patent. According to normal principles of interpreting documents, then, this would be the end of the matter.

In looking at question (ii) the court thought that the Improver questions could still provide helpful assistance, but the questions might require some reformulation. The court then proceeded to go over the Improver questions in ways which seem to this GuestKat rather reminiscent of a tutor marking an exam paper. The first Improver question was marked as "generally satisfactory". That question is posed like this:

(1) Does the variant have a material effect upon the way the invention works? If yes, the variant is outside the claim.

The second question however required some improvement. This question is only asked if the answer to question (1) is "no", i.e. the variant doesn't have a material effect. It was originally formulated like this:

(2) Would this (ie that the variant had no material effect) have been obvious at the date of publication of the patent to a reader skilled in the art?

In the court's view this question "imposes too high a burden on the patentee ... given that it requires the addressee to figure out for himself whether the variant would work". In the court's opinion, the second question would be better expressed "as asking whether, on being told what the variant does, the notional addressee would consider it obvious that it achieved substantially the same result in substantially the same way as the invention." Thus the second question should be asked "on the assumption that the notional addressee knows that the variant works to the extent that it actually does work."

The third Improver question was marked as "an acceptable test, provided that it is properly applied". This question is only asked if the answer to the second question is "yes", i.e. it would have been obvious that the variant had no material effect. The third question goes like this:

(3) Would the reader skilled in the art nevertheless have understood from the language of the claim that the patentee intended that strict compliance with the primary meaning was an essential requirement of the invention?

If the answer to that question "yes", the variant is outside the claim, and there is no infringement.

In relation to its comment about the need for question 3 to be "properly applied" the court made four points which it is worth setting out in full in order to try to grasp some of the subtleties of approach:
"First, although “the language of the claim” is important, consideration of the third question certainly does not exclude the specification of the patent and all the knowledge and expertise which the notional addressee is assumed to have. Secondly, the fact that the language of the claim does not on any sensible reading cover the variant is certainly not enough to justify holding that the patentee does not satisfy the third question. Hence, the fact that the rubber rod in Improver [1990] FSR 181 could not possibly be said to be “an approximation to a helical spring” ... was not the end of the infringement issue even in Hoffmann J’s view: ... it was because the rubber rod could not possibly be said to be a helical spring that the allegedly infringing product was a variant and the patentee needed to invoke the three Improver questions. Thirdly, when considering the third question, it is appropriate to ask whether the component at issue is an “essential” part of the invention, but that is not the same thing as asking if it is an “essential” part of the overall product or process of which the inventive concept is part. So, in Improver [1990] FSR 181, 197, Hoffmann J "may have been" ... wrong to reject the notion that “the spring could be regarded as an ‘inessential’”: while it was undoubtedly essential to the functioning of the “Epilady”, the correct question was whether the spring would have been regarded by the addressee as essential to the inventive concept, or inventive core, of the patent in suit. Fourthly, when one is considering a variant which would have been obvious at the date of infringement rather than at the priority date, it is ... necessary to imbue the notional addressee with rather more information than he might have had at the priority date."
In the circumstances, noting the weight that has been given by courts in the UK (and in some other jurisdictions) to the Improver questions, the court thought it right to express, in its own words, a reformulated version of those questions, whilst still emphasising, as Lord Hoffmann had said, that these questions are guidelines, not strict rules. The court's three reformulated questions are as follows:
i) Notwithstanding that it is not within the literal meaning of the relevant claim(s) of the patent, does the variant achieve substantially the same result in substantially the same way as the invention, ie the inventive concept revealed by the patent?

ii) Would it be obvious to the person skilled in the art, reading the patent at the priority date, but knowing that the variant achieves substantially the same result as the invention, that it does so in substantially the same way as the invention?

iii) Would such a reader of the patent have concluded that the patentee nonetheless intended that strict compliance with the literal meaning of the relevant claim(s) of the patent was an essential requirement of the invention?
In order to establish infringement in a case where there is no literal infringement, a patentee would have to establish that the answer to the first two questions was “yes” and that the answer to the third question was “no”. In this case the court was satisfied that the application of the three questions results in the conclusion that the Actavis products infringe. They achieve substantially the same result in substantially the same way as the invention. As to the second question, the notional addressee of the patent would appreciate that each of the Actavis products would work in precisely the same way as pemetrexed disodium when included in a medicament with vitamin B12. Investigating whether the free acid or other salts would work would be a "purely routine exercise". The court explained the difference in its view from that of the Court of Appeal and Arnold J. on the second Improver question by saying that, in relation to that second question, the lower courts had considered that the notional addressee should not be treated as knowing that the Actavis products did in fact work at all, whereas, as explained above, that seemed to the court to involve too strict a test.

On the third question, the Supreme Court thought that the Court of Appeal had adopted an approach which put too much weight on the words of the claim and not enough weight on article 2 of the Protocol. In doing so, the Supreme Court acknowledged that they, and Arnold J. at first instance, were following Lord Hoffmann’s guidance in Kirin-Amgen. Thus Floyd LJ. in the Court of Appeal thought that there was “no obvious leeway as a matter of language for giving [the claim] a broad as opposed to a narrow construction”. The Supreme Court saw that as a product of treating the issue raised by the third question as being one of normal interpretation, or, in the language of Sir Hugh Laddie, wrongly conflating the issue of interpretation with the issue of scope of protection. To take this approach, such that no departure from the language of the claim was permitted, would remove the point of asking the questions in the first place.

Thus, the Court of Appeal considered that the notional addressee “would understand that the patent was clearly limited to the disodium salt, and did not extend to the diacid or the dipotassium or ditromethamine salts”. In the view of the Supreme Court, the addressee of the Patent would understand that the reason why the claims were limited to the disodium salt was because that was the only pemetrexed salt on which the experiments described in the specification had been carried out. But it did not follow that the patentee did not intend any other pemetrexed salts to infringe. The court said that would confuse the disclosure of the specification of a patent with the scope of protection afforded by its claims. The court thought it very unlikely that the notional addressee would have concluded that the patentee could have intended to exclude any pemetrexed salts other than pemetrexed disodium, or indeed pemetrexed free acid, from the scope of protection. Therefore the Court concluded that, subject to considering the prosecution history, the Actavis products would infringe claim 1 of the Patent.

This GuestKat finds that conclusion a little surprising and is still digesting it. In view of the length already of this post, there will be a part 2 dealing with prosecution history and indirect infringement, and any other comments. At the moment, a pause for breath seems appropriate, before reaching any conclusions as to the effect of what seems to be a significant reboot of the approach to patent infringement in the UK courts.

96 comments:

LordBeefBurger said...

"The court thought it very unlikely that the notional addressee would have concluded that the patentee could have intended to exclude any pemetrexed salts other than pemetrexed disodium, or indeed pemetrexed free acid, from the scope of protection."

And yet this is exactly what the carefully chosen words of the patentee provided: an exclusion of any pemetrexed salts other than pemetrexed disodium.

It is worth pointing out that "disodium" is not a term amenable to variation in practice - this is not a situation like Catnic's "vertical". There are not degrees of sodium-ness, nor is another element more-or-less sodium, or for all practical purposes sodium. Had the patentee intended to protect something other than pemetrexed disodium, he had the linguistic tools in his bag to do so -"or another pharmaceutically-acceptable salt thereof", or some similar formulation.

I think this is a rather bleak day for legal certainty in the UK, and therefore chilling on innovation.

It also rather puts a mocker on the EPO Examiners who expend such time and ink to pounce on any allegedly-impermissible intermediate generalisation. The Examiner insists that the Applicant write in the specific, not the general term - for the Applicant must not improve his position, must he? - and lo-and-behold, the Courts delete the specific and replace it again with the general term.

I wonder what would have happened had there been an Art 54(3) document disclosing another permetrexed salt? The Court says the claim to disodium covers it: would the disodium claim lack novelty over such a reference?

A rum judgment all in.

Gilman Grundy said...

Yes, the idea that the UK may now have something amounting to file-wrapper estoppel as a result of this decision including prosecution history seems possibly a bigger change that the amendments to the Improver questions made in this case.

MaxDrei said...

I'm also surprised, as a first reaction, Stephen. But, on thinking about it, not so surprised. I should say that I've read your write up, above, but the Decision itself, not yet.

If you (the Inventor or Applicant) have only got results for Na, and the Paris priority year is ending, what can you get out of the EPO other than a claim limited to Na? But does that mean you are entitled to no more scope than that? Is it "fair" to confine your scope to Na alone?

What is the law in Germany on Doctrine of Equivalents? I suspect the SC is bearing in mind that it has to i) lay down law compatible with the reality of prosecution at the EPO, and ii) give due deference to the jurisprudence of Germany. I guess it was fully briefed on what the BGH says about any DoI.

And, quite apart from BREXIT, it should bear those two things in mind, shouldn't it?

Tim R said...

Important decision. Quotes Laddie. Meaning of claim not identical with scope of protection. So Convatec problems vanish.

Anonymous said...

LordBeefburger, as I read your comment, with which I agree, I get a feeling of deja vu. Could it be the similarity to the comment made earlier on the breaking news post? It may explain why I agree so.

Anonymous said...

MaxDrei, in the invention covered by the patent, had the inventor only had data for the sodium salt of pemetrexed as you suggest, they would have been able to claim the use of pemetrexed in many other forms, including the potassium salt, free acid, or indeed any pharmaceutically acceptable salt thereof.

In other cases, the applicant will be entitled to whatever they are reasonably entitled at the end of the priority year, which is 'fair'.

Tim Jackson said...

"...does the variant achieve substantially the same result in substantially the same way as the invention, ie the inventive concept revealed by the patent?"

This bears more than a passing resemblance to the US doctrine of equivalents. A common US formulation stems from the Graver Tank case, asking if a claim feature:

1. Performs substantially the same function
2. In substantially the same way
3. To yield substantially the same result

Paragraph 42 of the present decision discusses Lord Hoffman's rejection of the Graver Tank approach in Kirin-Amgen.

In US actions I've been involved in, much effort has been expended in addressing the presence or absence of each of those three elements of the test. For example, it's not enough if the feature concerned performs the same function and yields the same result but in a different way.

One distinction is that the US doctrine is applied to individual claim limitations, and not to the claim as a whole. Does an individual feature of the alleged infringement perform the same function in the same way to yield the same result as the corresponding individual claim limitation?

In contrast, while the present case applies the test to a "variant", it seems to ask whether it achieves substantially the same result in substantially the same way as the invention as a whole, i.e. the inventive concept revealed by the patent.

PerplexedOfTunbridgeWells said...

I too am worried about the Art 54(3) point. If a claim defining "sodium" now encompasses in its scope "potassium", how should an applicant formulate his claim to be clear of Art 54(3) art disclosing potassium, but not sodium? Or now does the test of "disclosure" have now to encompass that which is directly and unambiguously disclosed and also Improver equivalents thereto? Or, put another way, where is the EPO's Gold Standard now?

How do the Germans sort this out, with their DoE?

MaxDrei?

Observer said...

I would agree with LordBeefBurger and the GuestKat that this judgement is quite surprising.

When considering that the original disclosure only relates to disodium, stating that dipotassium also falls under the scope of the claims, would mean that actually in such a situation the applicant/proprietor could amend its specification after filing in order to envisage any other salts which were not specifically disclosed in the original application.

Even if one would not adopt the strict approach of the BA of the EPO, there is no doubt that such an amendment would plainly offend Art 123(2) EPC.

When one looks at the contribution to the art, the proprietor has only disclosed the association of permetrexed disodium with vitamin B12 or a pharmaceutical derivative thereof, and nothing else. There is well a general statement in § [0005] and [0022] of the patent referring to antifolates as a class associated with a methylmalonic acid lowering agent as vitamin B12. But that’s it.

All further statements in the patent refer exclusively to permetrexed disodium. See for example § [0010], [0011], [0016], [0034], [0039], [0045] or [0047] of the patent specification. The judgement refers to some of those §, but then takes a different route.

The limitation to permetrexed disodium is thus a clear choice of the proprietor. Why the proprietor should then be allowed to obtain protection for something he has not invented? I fully agree with LordBeefBurger “that "disodium" is not a term amenable to variation in practice”. It cannot be compared with “vertical” in Catnic.

The problem with Art 2 of the Protocol on Art 69 in EPC 2000 is that, although it mentions equivalents, the diplomatic conference was not able to reach an agreement on the definition of what is an equivalent. The EPO had made proposals to this effect, but no agreement could be reached. Taking pretext of this new article in the Protocol to go as far as here is quite daring and certainly not enhancing certainty in UK.

One gets the feeling that the mistake done in the Epilady case had to be corrected and a more lenient stance adopted. And for this it was convenient to rely on Art 2 of the Protocol.

The judgement might look interesting, but it should remain a one-off, as in my opinion it totally disregards the actual contribution to art by the proprietor.

Snackfood supported said...

I think that now we are Brexiting we can return to formulating our own unique case law and making our purposive construction doctrine broader, without needing to worry about the way Europe or the EPO look at claim language.

The EPO have increasingly viewed the 'invention' as the literal claim scope since getting rid of the Snackfood test (https://www.epo.org/law-practice/case-law-appeals/recent/t880073ep1.html)

At least the UK can now go back to reconsidering claims and inventions based on essential and non-essential features, and not let limitations relating to non-essential features get in the way of catching infringers using the same the invention.

MaxDrei said...

Still not had time to read through the decision but let that not stop me indulging myself with a rant.

Through the second half of my long career as a patent agent/attorney, I have defended "purposive construction" against the notion of "infringement by equivalent". The notion that the claim means the same, whether for validity or infringement, is precious to me. You know, the notion that "What comes after, and infringes, if coming before, anticipates". You know, the notion that the Act provides only one sort of infringement and there is no justification to debate whether any given act of infringement is "direct" infringement or infringement "by equivalent".

I remember at a Seminar about 20 years ago, when discussing not Improver but HILTI, speaker Nick Pumfrey cautioned me that such a notion might seem to me unassailable while being simultaneously given no houseroom at all, on The Continent.

What chance does the UK SC have, of getting to the right result, when both sides are represented by professional litigators for whom, the more legal uncertainty there is, the more money they can make? Who is there to point out to the judges the perils and unwisdom of overturning a century of established patent law? One would like to think that the wisdom of the vastly experienced patent judges in the High Court and Court of Appeal would carry more weight. But no, weight is instead given to the jurisprudence of non-specialist, indeed generalist, judges in the civil law jurisdictions of Continental Europe, for whom Binding Precedent is what you find on a Different Planet, but not on grounded Earth.

There are ways and means, in civil law jurisdictions, to live with legal uncertainty. See how the EPO Enlarged Board of Appeal has brought an unprecedented level of certainty to the law of novelty, obviousness, clarity, added matter, sufficiency, Convention priority. Poisoning an English law jurisdiction with a near fatal dose of it though and what do you get? Litigate like in America? Do you know over there how to construe a claim, or what is or is not definite, enabled, enjoys sufficient written description, entitled to priority, old or obvious?

Somebody asked me about Germany. I'm not qualified to advise. But here is a thought to play with, nevertheless. Take the claim, construe it (purposively, if you will) assess validity, assess if there is "direct" infringement. You are nearly done.

Just one more thing, equivalence. Is it "fair" to go outside the claim scope, to nail the infringer? Would it do un"reasonable" damage to "legal certainty" so to nail the infringer? If not, nail him.

But what if he has a Gillette Defence, that his act, whether or not it touches validity of the claim as you have construed it, is nevertheless no more than an obvious variant of the prior art. In Germany, it works. They call it their "Formstein" defence.

HILTI by the way was the case in which a Swiss patentee litigated its patent all over EPC-land. It lost in every jurisdiction bar one. But the reasons were different in each jurisdiction. Which was the one jurisdiction in which it prevailed. Go on, you can probably guess: their home jurisdiction CH.

There is a lot wrong with Europe. We should harmonise. I suppose that's what the SC in this case has in mind. but was the sacrifice worth it?

BTW, does any reader remember the Chef America case about the bread-making oven. The claim recited heating the dough "to" 400°F when they meant baking it "at" 400°F, that is, an oven temperature of 400°F. How to construe that claim then, to be "fair" to its owner. With purposive construction, no problem. But how does one apply a "Doctrine of Equivalents" to such a claim element? I for one lament the sacrifice of purposive construction on the international altar of the appalling DoE.

John said...

It needs to be remembered that one purpose of Supreme Court decisions in all jurisdictions is for basic principles of case law to be invented or substantially changed, and then the lower courts and patent offices need to deal with the fallout on individual future cases. The take home message here is that it is time to reconsider how we are going to deal with equivalents.

As the previous comments have pointed out the present decision will cause issues in validity, and the next 10 years will be a sort of experiment as to how the patent system deals with that. Perhaps validity does need to get stricter in some way, and if that leads to narrower (literal) claim scope on granted patents that might benefit the system in the long run.

Jeremy (non Kat) said...

This means that the scope of protection for infringement goes beyond the meaning of the claim, but the test for novelty uses only the meaning of the claim without the extra scope provided for infringement. So a granted patent covers more than what it had to overcome in order to be granted.

It's not the judgement's fault - the problem is with paragraph 2 of the Protocol to Art 69 which sets up this situation. The judge has simply applied what it says rather than trying to come up with a way to ignore it (as in Kirin Amgen).

I would argue that "a fair protection for the patent proprietor with a reasonable degree of legal certainty for third parties" (from paragraph 1 of the Protocol) can only be achieved by NOT having a doctrine of equivalents, as having a different scope of protection for infringement than for interpretation of novelty is not fair. But that makes the "due account" to be taken of equivalents from paragraph 2 of the Protocol be "no account" of equivalents! That interpretation is clearly unreasonable so we must take some account of equivalents when considering infringement and must therefore allow patents to cover more than what the claims state.

It's a sad place to be but that's the law our country has signed up to with EPC 2000.

Anonymous said...

The Protocol only relates to the scope of protection conferred by the claims, and it does not apply to the issue of validity. The law therefore accepts that a patent claim may encompass what has gone before. It is valid, but infringed.

Had the Lilly case been an example of such a situation (i.e. the prior art disclosed the potassium salt) the judges may have been more aware of the implications of their poor judgement, and may have tread more wearily. In the present case, a claim literally covering the potassium salt (i.e. the claim used the word 'potassium' in big bold letters with flashing lights and dancing nubile naked dancers pointing at it) would have been valid on the grounds of novelty and inventive step and sufficiency, but such a claim would have been rejected for added matter.

When watching sections of the Supreme Court hearing, I got the impression that most of the judges had no grasp of the issues or understanding of patent law. A couple of judges, including Neuberger, fared better, but still they showed a dangerous ignorance in many of their questions.

Re Snackfood's comment: Brexit doesn't come into it. You sound like one of the Supreme Court judges.

I am, myself, looking forward to some more original insight from the Beefburger. Copy and Paste, M'Lud? Can you advise us to follow the US attorney strategy in future? "Draft narrow, claim broad"? Is 'Observer' correct that the judgement should remain a one-off? Or would my Learned Friend advise that a decision of the Supreme Court is no such thing? Pray tell!

Anon said...

I am going to go against the grain of the earlier comments and say that this decision seems to make sense. There has long been a disconnect between Article 69 and UK law. This decision seems to address it, without going through the intellectual hooplah of Kirin-Amgen. While Kirin-Amgen is superficially beautifully simple as Lord Neuberger says here, it does not answer the question of equivalents which fall outside any reasonable interpretation of the claim.

As for "file wrapper estoppel" (note, it isn't even called that) the judgement is clear: it can only be useful when it is useful.

Observer said...

Bringing in the problem of priority offers an interesting perspective.

The decision boils down to alleging that if in the priority document there is sodium, then the priority is as well valid for potassium. If this is true, then we are back to the uncertainty generated by Snackfood (T 73/88). The boundaries of the protection are not clear and any third party is at the risk that he might be an infringer in spite of being clearly outside the claim.

If taken to its face value, this decision might be fatal to the patent system by the creation of a new type of torpedoes, this time not trans-border, but as far as validity and scope of protection is concerned.

It is not at all manifest, especially in pharmacy that replacing one alkali metal with another the pharmaceutical properties remain the same. It seems that there is no guarantee in this respect. Why the proprietor did not try the other alternatives now considered infringing when filing his application?

If the applicant/proprietor has chosen to limit his claim to sodium, then he had good reasons to do so. Claiming later that it also encompasses potassium, or worse an alkali metal, is allowing him to protect an invention which he has not done.
The only inventive concept disclosed in the patent is that with sodium, nothing else.

For that reason alone, the decision is to be taken with caution, and should not be generalised all over Europe.

If in the priority document there is sodium, or potassium and the later filing claims an alkali metal, then the priority is only valid as far as sodium and potassium are concerned. Here the notion of partial priority as exemplified in G 1/15 comes to application.

If the claim means the same, whether for validity or infringement, then this decision is highly problematic.

As long as Art 2 of the Protocol on Interpretation of Art 69 does not define what is to be understood by an equivalent, then it should be left where it is, and no conjectures about what could be an equivalent be uttered.

Anonymous said...

@Anon 16:40 but how do equivalents that have nothing to do with the claims fall within Article 69 which says

"The extent of the protection ... shall be determined by the claims."

Doesn't Art 69 itself (rather than the protocol) "answer the question of equivalents which fall outside any reasonable interpretation of the claim"?

Kant said...

I suspect innovator pharma companies (that develop novel compounds) will be pleased at this result, as it means their chemical formulae have got broader. However it is harder to predict the effect on downstream formulation/administration schedule/patient group cases (used for evergreening), and presumably innovator companies could suffer as such downstream cases will effectively now have broader claims for infringement, and so their competitors will also be at an advantage.

At first glance it is not easy to see whether or not this is a pro-pharma decision.

Anonymous said...

It's great to go against the grain and debate the point, but you only say it makes sense, without any justification. elaborate and debate.

Observer said...

Bringing in the problem of priority offers an interesting perspective.

The decision boils down to alleging that if in the priority document there is sodium, then potassium is as well encompassed by the claim. If this is true, then we are back to the uncertainty generated by Snackfood (T 73/88). The boundaries of the protection are not clear and any third party is at the risk that he might be an infringer in spite of being clearly outside the claim.

If taken to its face value, this decision might be fatal to the patent system by the creation of a new type of torpedoes, this time not trans-border, but as far as validity and scope of protection is concerned.

It is not at all manifest, especially in pharmacy that replacing one alkali metal with another the pharmaceutical properties remain the same. It seems that there is no guarantee in this respect. Why the proprietor did not try the other alternatives now considered infringing when filing his application?

If the applicant proprietor has chosen to limit his claim to sodium, then he had good reasons to do so. Claiming later that it also encompasses potassium, or worse an alkali metal, is allowing him to protect an invention which he has not done.

The only inventive concept disclosed in the patent is that with disodium, nothing else.

For that reason alone, the decision is to be taken with caution, and should not be generalised all over Europe.

If in the priority document there is sodium, or potassium and the later filing claims an alkali metal, then the priority is only valid as far as sodium and potassium are concerned. Here the notion of partial priority as exemplified in G 1/15 comes to application.

If the claim means the same, whether for validity or infringement, then this decision is highly problematic.

As long as Art 2 of the Protocol on Interpretation of Art 69 does not define what is to be understood by an equivalent, then it should be left where it is, and no conjectures about what could be an equivalent be uttered.

Tim Jackson said...

I don't see the validity problem that has been posed by several posters. The doctrine of equivalents is a test for infringement, not validity.

The Supreme Court has been clear that the scope of the equivalents is controlled by the inventive concept of the patent.

The inventive concept surely cannot include anything which is not novel or which is obvious from the prior art. There is therefore no possibility to obtain protection for subject matter which would be invalid.

MaxDrei said...

Good point, very early this morning, from Tim Jackson. At 14:54 yesterday I cited the Formstein Defence in Germany. Tim suggests its new counterpart in the UK.

Either way, if the accused embodiment isn't part of the concept that's "inventive" over the art, no infringement. Germany bifurcates infringement and validity, England not, but both get you (now) to the same end result.

Or not?

Kant said...

Is it not strange that another poster has taken to using the same name I have been using for the past couple of years?

Kant (the original) said...

Max, that is the classic UK "squeeze" is it not? "If your claim is broad enough to include my product within the scope of protection, it is invalid."

PerplexedOfTunbridgeWells said...

But Max, Max - what about 54(3) art? How does Formstein/Gilette "obvious variant" deal with that? Would the presence of a 54(3) dipotassium disclosure remove the equivalent from consideration (change the scope of the claim) or render the claim invalid? Are we now at the unsatisfactory position reached in Designs law, that the scope of protection depends on the available art in front of the Judge? And such a circumstance, how should Proprietor amend to restore validity? Rather like Brexit meaning Brexit, how can Proprietor ensure sodium means sodium?

For those who think this is a one-off, binding precedent ensures that it will not be.

Is this anticipating the "harmonisation" that the UPC is hoping to bring? I was all ready to advise clients to keep litigating in the UK, as the predictability of law and decisions would likely be better. But if our SC keeps at it, they may be doing themselves out of a job.

Observer said...

Dear Tim Jackson,

This is exactly what has happened. If you start distinguishing validity from scope of protection then then the scope of protection becomes as uncertain as uncertain can be.

One could go as far as saying that Art 123(3) has indirectly been grossly ignored. The scope of protection has been extended to something which does not have been disclosed.

If a limitation to permetrexed disodium can be generalised, to any other permetrexed compound, including other permetrexed salts and the free acid, without any support in the application as filed, then something is going wrong.

The only inventive concept disclosed in the patent relates to permetrexed disodium in spite of all the generalisations which have been attempted in the patent, and especially in its introductory part.

It might thus be true that the original claims were very general and merely related to antifolates and vitamin B12 (to simplify the matter), but the only proper example given was permetrexed disodium. Contrary to what is stated in the decision, cf. § 89, the examiner was right to request limitation of the claims to the examples given which only related to the said permetrexed disodium.

When limiting his claim as requested, the applicant announced that might file divisional applications. He does not seem to have done so. Why not? It is not infrequent for an applicant to accept a limited claim in order to get a quick grant, but if he is sure of his disclosure, he then files a divisional with broader claims.

If in the application as filed it would have been indicated that the teaching with permetrexed disodium is only an example but it can be generalised, to any other permetrexed compound, including other permetrexed salts and the free acid, then the court examiner could have asked proof of the allegation and it would have been easy to clarify the matter by the applicant. But we do not even have that. The decision is full of conjectures and suppositions.

In any case it would not have been necessary to resort to using a doctrine of equivalents which does not have any support in the EPC, in order to bring under the claim wording something which squarely is not in it.

The decision wanted to bring something in the patent which was not originally disclosed, and for which there is no directly and unambiguously derivable general contribution to the art, beside some nice generalising sentences at the beginning of the patent.

Elly Lilly might be happy with the present decision, but should the court persist in its error, the table might turn against it in the future. Once you are proprietor and the next time you are infringer/opponent. You cannot always win.

In any case this decision is not bringing any peace in the field, it rather stirs up problems, and like one commenter said, the next 10 years will be a sort of experiment. I am not sure that the patent system will profit from it.

And then we might have the UPC which will makes things a bit more complicated.

MaxDrei said...

This is going out to Tunbridge Wells (and the Kants).

I think that the key to grasping the new landscape is to de-couple validity and infringement. Grasp that the law of validity has not changed. It is just that even if you act outside the meaning of the claim you can still infringe. Not "directly" but under the DoE. Re-read Tim Jackson. OK?

Perhaps the comparison with Reg Des law is valid. Beyond my competence to comment on that.

Proof of the pudding said...

I shall try again, as my post from yesterday did not make it through.

I am troubled by the fact that the Supreme Court's judgement appears to create new categories of subject matter that fall within the extent of protection of the claims, namely:
(A) subject matter that has been found to be unpatentable (eg on the grounds of Art. 123(2) EPC) but not for "prior art" reasons; and
(B) subject matter that has not been examined for patentability.

Provided that category (A) also excludes embodiments for which the patent does not provide a sufficient disclosure, I could see how it might (just) be acceptable to interpret the patent monopoly as covering that category of subject matter.

It's a different kettle of fish for the category (B) matter, though. I mean, what possible justification can there be for awarding a monopoly for subject matter that has simply not been examined?

With regard to category (B), let us remind ourselves that the EPO does not examine beyond what the Supreme Court would term a "normal interpretation" of the claims:

http://www.epo.org/law-practice/legal-texts/html/caselaw/2016/e/clr_ii_a_6_3_1.htm
In T 2221/10 the board referred to established case law according to which the description can be used as the patent's "dictionary" to assess the correct meaning of ambiguous terms used in claims (see in this Chapter II.A.6.3.3). However, if a term used in a claim has a clear technical meaning, the description cannot be used to interpret such a term in a different way. In case of a discrepancy between the claims and the description, the unambiguous claim wording must be interpreted as it would be understood by the person skilled in the art without the help of the description.

In T 197/10 the board explained that if the claims are worded so clearly and unambiguously as to be understood without difficulty by the person skilled in the art, there is no need to use the description to interpret the claims. In the event of a discrepancy between the claims and the description, the unambiguous claim wording must be interpreted as it would be understood by the person skilled in the art without the help of the description. Thus, in the event of a discrepancy between clearly defined claims and the description, those elements of the description not reflected in the claims are not, as a rule, to be taken into account for the examination of novelty and inventive step
.

With this in mind, does the SC's judgement mean that any application for a Declaration of Non-infringement should always be combined with an action for revocation of the patent... just to allow for a "squeeze" argument to be run in respect of an "equivalent" that was not examined for patentability pre-grant?

For example, what would the SC have made of an "equivalent" that, instead of a different salt form of pemetrexed, used a completely different anti-folate? As far as I can see, there is nothing in the SC's judgement that would, in principle, prevent the claim from covering such an equivalent... even though the EPO clearly did not consider whether such an equivalent would satisfy the patentability requirements of the EPC (including "substantive" requirements, such as inventive step).

Kant said...

To me, this decision of the SC is simply confirming the recent practice of the lower courts, referring directly to the protocol, e.g. Birss J.:

"Finally I will consider the Protocol on the Interpretation of Art 69 EPC directly. To interpret the claim as covering a single conceptual access class bit rather than a physical bit takes due account of equivalents as a matter of claim construction (see Art 2 of the Protocol)." [2015] EWHC 1034 (Pat)

Jacko said...

This judgment is a good indication of the disconnect between English judges (and counsel, I suspect) and the EPO regarding added matter by intermediate generalisation. Any EPA would regard the EPO's requirement to limit the claims to the sodium salt as quite normal. The patent application did not suggest that other salts would do and the expert evidence relied upon was clear that the skilled person would not know from the specification whether or not the potassium salt would be useful. However, the SC court plainly thought it unfair that the patentee had been required to limit its claims to the sodium salt, thereby extending protection to the very subject matter that the EPO had required the applicant to exclude.

To do so in the light of the facts of the case, the SC's new test brings in an ex post facto test for equivalence, whereby the skilled person is deemed to know that the variant (here potassium) actually works.

This leads to a problem with the Gillette defence (and so I disagree with Tim J). Firstly, as a general proposition, it does not logically follow that because A is obvious from B that B must be obvious from A. Secondly, the SC's equivalence test allows for knowledge regarding efficacy that was not available to the skilled person at the priority date.

Consider a claim to A, which was both novel and inventive over prior art B at the priority date. Later, it could be discovered that B is an effective equivalent to A. This later discovery could bring B within the ambit of the new infringement test without disturbing the validity of the claim (since the test for novelty and inventive step is unchanged).

Proof of the pudding said...

Interesting comment from Tim Jackson:
The inventive concept surely cannot include anything which is not novel or which is obvious from the prior art. There is therefore no possibility to obtain protection for subject matter which would be invalid.

Unfortunately, it appears to me that the SC found a way to (explicitly) scupper even that get-out. This is most evident from the second of their reformulated "Improver" questions:
Would it be obvious to the person skilled in the art, reading the patent at the priority date, but knowing that the variant achieves substantially the same result as the invention, that it does so in substantially the same way as the invention?

In other words, the "inventive concept" of the patent encompasses variants for which hindsight is required to identify a connection with the original invention.

Now, is it really fair to say that the "inventive concept" of a patent extends to "variants" that no one would have expected to work (in the same way as the invention) at the time the invention was made? Whilst it is perhaps acceptable to encompass future inventions from within the (literal) claim scope of a patent, remember that the SC is only talking about "variants" that fall outside of a "normal" interpretation of the claims.

Is it not absurd to allow hindsight to infect the assessment of the "inventive concept" of a patent? Does this not risk subtle morphing of that concept in order to "capture" the allegedly infringing "variant"? And most importantly, how does this provide "a reasonable degree of legal certainty for third parties"?

RB said...

Im not sure I follow the suggestions above that this test only applies for infringement but not validity.

If that is the case then what is the point of the 3rd question? Why would the patentee ever have "intended" that strict compliance was essential?

If this extra breadth to the spec is only either positive for the patentee and has no downsides, then the patent drafter will always want the answer to the third question to be "no" and in future the answer would persuasively only be "yes" through drafting error. If every applicant just adapts the typical American "spirit & scope" boiler plate to say "The claims are intended to cover all immaterial variants and nothing in the patent should be taken to mean that strict compliance with the literal meaning of the any of the claims is an essential requirement" the third question would be obsolete.

I currently read the third question as meaning that this also determines the scope for validity.

Gilman Grundy said...

@Anon 16:40 -

"As for "file wrapper estoppel" (note, it isn't even called that)"

It's a common name for it, no? And slightly less of a mouth-full than "Prosecution history estoppel".

"the judgement is clear: it can only be useful when it is useful."

Clear as mud. Particularly the part about prosecution history being "at least according to what we were told... unlikely to be extensive" and therefore easily read and understood!

The following section of the judgement particularly screams "You can now use the prosecution history to limit the scope of the claims when considering infringement" (which is thecore of what prosecution history estoppel is) to me:

"[Circumstances where prosecution history is relevant can] be exemplified by a case where the patentee had made it clear to the EPO that he was not seeking to contend that his patent, if granted, would extend its scope to the sort of variant which he now claims infringes"

So if the prosecution history includes a statement from the applicant saying that "My claim to AB+C has inventive step over the prior art references 1 and 2 respectively showing AB and D, because D is not C, and thus combining AB and D will not result in AB+C" then I may confidently launch my AB+D product free from concerns that AB+D may be considered a variant of AB+C and thus infringe a patent claiming AB+C? Even if there were other arguments used during prosecution - e.g., that even if D were to be considered to fall within the definition of C it was not obvious to combine AB and D?

More generally, my biggest concern with this ruling is that the entire reason why the Lilly amended their claim to be narrower was that there was no support for anything broader. This was not a case of carelessness in claim drafting, in fact had the specification contained more possibilities, but only claimed one of them, it seems possible that the court might have said that these possibilities had been excluded on purpose and therefore should not be included as variants. Lilly have thus been, in a sense, rewarded for not disclosing more. This overturns the idea that a patent monopoly is a reward in return for a disclosure.

PerplexedOfTunbridgeWells said...

Max says:
"the key to grasping the new landscape is to de-couple validity and infringement"

Wow.

MaxDrei said...

So many new comments this morning. Not had time yet, to mull them all over.

But another thought occurs to me, namely that the SC is recognising as reality the established jurisprudence of the Boards of Appeal of the EPO, in particular when it comes to prosecution amendments and how restrictive the established practice is.

After all, Robin Jacob used to say that the EPO White Book took pride of place amongst the works of reference he relied upon.

The DoE is required, thinks the SC, in order to do justice in the real world of prosecution at the EPO.

MaxDrei said...

Today, Tunbridge reacts with just one word "Wow" to my (Tim Jackson inspired) suggestion that validity and infringement are somehow de-coupled. But then up pops Pudding, to suggest that the assessment of what invalidates and what infringes is indeed different. You can use hindsight knowledge to decide what is an infringing "equivalent" but not when assessing validity.

You know what, this "hindsight" distinction; I think it is the established caselaw in Germany.

So, the UK SC just aligned itself with not only the White Book but also with the BGH. A masterstroke, eh!

PerplexedOfTunbridgeWells said...

I always understood the "White Book" gold standard was to prevent an unwarranted advantage in terms of claim scope by amending to cover that which was not foreseen, with a side helping of legal certainty to allow third parties to understand, from the A-publication, the scope of claim which might be permitted in the B-publication.

Eli Lilly blows all that out of the water, no?

But I take the BGH point. Is this a pre-UPC alignment, to make sure that when the German-inspired UPC comes into being, UK courts will not have to have different strands of case law for their own jurisdiction and those patent which are in the shared jurisdiction of the UPC?

Proof of the pudding said...

It is now pretty settled in the case law of the EPO that, if inventive step is based upon providing a solution to a certain objective technical problem, then it is not possible to recognise the presence of an inventive step for embodiments of the invention that (at the relevant priority date) do not plausibly solve that problem.

It is not hard to see that this approach to inventive step really does not square with the Supreme Court's view that a "variant" falls within the scope of a claim if information provided long after the priority date of the claim shows that it works in the same way as the "worked" embodiments.

So, could we have the situation where, in the UK, a patent claim is found to protect a "variant" that the EPO ruled to be non-inventive (as not plausibly solving the OTP at the priority date)? Or is this an instance where the prosecution history would come to the rescue of the alleged infringer?

And if prosecution history can be relied upon in that instance, does this mean that the patentee is likely to have more luck arguing equivalence for "variants" falling outside of the literal claim scope (which would, of course, not have been examined by the EPO) than those falling within the original claim scope (but which the EPO forced the applicant to delete from the claim)?

What a strange world we live in!

MaxDrei said...

Not yet sure that Tunbridge is right, that the EPO ship is blown out of the water by this Decision. Not yet sure that Pudding is right, that with this Decision we suddenly live in a world that is "strange".

I think the SC just thought it just (and in accordance with the fairness required by the Art 69 Protocol) and in line with The Continent, that Lilly should have a scope that reaches as far as dipotassium, and ruled accordingly. Until now, Europe has thought the UK to be the strange one. Just as lawyers in the USA think it only a matter of time until the rest of the world adopts US law, and German litigators think it only a matter of time before the rest of Europe adopts German law, so some lawyers in England continue to think it only a matter of time before The Continent comes round to acknowledging the superiority of English jurisprudence. We know now that the SC knows better.

Proof of the pudding said...

Max - it is not because of following any particular line of jurisprudence that I find the SC's decision "strange". It is because of its practical consequences. Do you have any comment on those?

Tim Jackson said...

Proof of the Pudding, you suggest (at 09:48) that the SC's second question scuppers the idea that the scope of equivalents cannot extend to subject matter which would be invalid.

Sure, the second question allows the use of hindsight when determining the scope of equivalents. But the scope still remains subject to the first question. The variant has to achieve the same result in the same way as the inventive concept. The second question cannot expand the scope beyond the inventive concept to subject matter which is not inventive.

At 09:14, you suggested that the SC has extended the scope of protection to "(B) subject matter that has not been examined for patentability" by the EPO. However, when the courts are determining the inventive concept of the patent, I'm sure they will be perfectly capable of examining any prior art that wasn't before the EPO, and setting the maximum scope of equivalents accordingly.


Tunbridge, your Article 54(3) problem may need to be the subject of a future decision. In paragraph 66, Lord Neuberger specifically allowed that the reformulated questions are only guidelines, that may have to be adapted to the specific facts of a particular case.

However, I can see a possible straightforward solution. Article 54(3) is a carve-out from the law relating to inventive step, in the case of unpublished prior art. So when assessing the inventive concept that controls the scope of equivalents, perhaps the future court should make a corresponding carve-out of the unpublished Article 54(3) prior art, using the Gillette case (part of English infringement law for over a century). In your example, the equivalents would not include dipotassium, for which there is a novelty-only Gillette defence. But the equivalents would include the free acid and other salts which achieve the same result in the same way as the patent, for which no Gillette defence would be available.


Observer, you suggest that the scope of protection will be extended contrary to Article 123(3). But Article 123(3) only governs amendments to the patent. Determining the scope of equivalents does not involve an amendment.

Anonymous said...

"In the view of the Supreme Court, the addressee of the Patent would understand that the reason why the claims were limited to the disodium salt was because that was the only pemetrexed salt on which the experiments described in the specification had been carried out....." - so does this startling conclusion mean that the Supreme Court is saying if you have only built one prototype of a mechanical invention it is safe to put all the dimensions, material specs, etc. of that prototype into your claim 1 because infringement won't need to include such details???!!!

Proof of the pudding said...

Tim - with respect, I must disagree with your statement that "The second question cannot expand the scope beyond the inventive concept to subject matter which is not inventive". This is because I believe that you are forgetting the "must plausibly solve the objective technical problem" bit of the EPO's analysis on inventive step (see my comment from 12:36 today).

Indeed, it could be argued that the SC has construed Lilly's patent to encompass embodiments that the EPO found to be non-inventive on this ground.

Tim Jackson said...

@Proof of the Pudding -

In deciding on the scope of the equivalents, you have to follow the SC's reformulated rules. To be an equivalent, the first and second questions must be answered 'yes', and the third question 'no' (paragraph 66, final sentence).

So the answer to the first question would have to be that the variant does achieve substantially the same result in substantially the same way as the inventive concept of the patent.

Even if that is decided with the benefit of hindsight under the second question, presumably the variant will still solve the objective technical problem found by using the EPO's problem-solution approach.

In any case, if you are looking for consistency between the treatment of infringement and inventive step in an English court, I think you should be looking at the English courts' Windsurfer/Pozzoli approach, rather than the EPO's problem-solution.


At 12:36, you characterised the EPO approach as: "if inventive step is based upon providing a solution to a certain objective technical problem, then it is not possible to recognise the presence of an inventive step for embodiments of the invention that (at the relevant priority date) do not plausibly solve that problem."

I'm not quite sure where that precise wording comes from. However, it is true that the EPO requires that the objective technical problem be formulated on the basis of information available at the effective date of the patent. See here. And it is also true that post-published evidence may not serve as the sole basis to establish that the problem is solved. However, it can be taken into consideration as supplementary evidence. See here.

In your hypothetical situation, one assumes that the EPO satisfactorily formulated the objective technical problem and found that it was solved by the claimed invention, all on the basis of information available at the effective date, not including the variant subsequently discovered in hindsight. However, had they subsequently been told of that variant, and that it achieved substantially the same result in substantially the same way, I don't see why they wouldn't take that supplementary evidence into consideration.

I therefore don't follow your question: "So, could we have the situation where, in the UK, a patent claim is found to protect a 'variant' that the EPO ruled to be non-inventive (as not plausibly solving the OTP at the priority date)?" I don't think the EPO will have made any such ruling.

Observer said...

To Tim Jackson,

You are right, strictly speaking Art 123(3) is not infringed. I just said that Art 123(3) was indirectly ignored. What I meant to say is what the SC did is de facto extend the scope of protection on something which was never disclosed and envisaged at the filing date.

As another blogger put it, one can also consider that the SC simply added subject-matter to the application as filed. Had the applicant during prosecution wanted to include other permetrexed salts and the free acid, in the absence of any support in the application as filed, then the application would have been refused under Art 123(2). Why should he obtain protection for something which he had not envisaged at filing? What is Art 123(2) for?

A monopoly is granted for a contribution to the prior art. The contribution to the art was permetrexed disodium and nothing else. The claims as such are as clear as clear can be, and any interpretation on what could also be falling under their wording is pure conjecture. It is therefore disturbing that the proprietor has obtained a reward for something he never envisaged.

The decision might be a nice play on what could be or are equivalents, which are not defined whatsoever in the Art 2 of the Protocol, but it extremely dangerous due to the uncertainty in scope of protection and added-subject-matter it brings in the system.

The whole concept of directly and unambiguously derivable has been totally disregarded. What has not been disclosed should not be protected at any time during prosecution and during the life of a patent. I am not sure that the members of the SC have been aware of the problems they would bring in when they took their decision.

I therefore maintain my opinion that this decision is wrong in the circumstances it was taken, i.e. in presence an absolutely clear claim and a corresponding disclosure. May be in situations like “vertical” it could be of some use, and even this remains to be seen.

MaxDrei said...

Me, I'm right behind Tim Jackson and nonplussed by those remarks just now from "Observer" who seems to make the tyro's mistake of confusing what a patent application discloses with what a claim covers.

The whole point of claim drafting is to cover embodiments your competitor will come up with, upon reading your patent and grasping your contribution to the art. It is hard enough to write a good claim, but even harder to foresee the details of the embodiments your competitor will offer to the market.

Especially in pharma, where nobody knows which other salts will work till they have tested them. And those tests, while no more than routine non-inventive activity, do actually take considerable time to carry out.

Observer said...

Dear Max Drei,

I am fully aware of the differences of what a patent application discloses and what claims may cover, but in the circumstances I maintain that the decision is wrong as it makes the claims cover something which was never envisaged by the proprietor.

In the present circumstances(I insist upon this proviso), he got protection for something he did not contribute to the art.

Let's at least agree that we disagree

MaxDrei said...

Not yet ready to agree with you, Observer, that we disagree. It might be that we agree in substance but are not quite achieving perfect communication.

Can we agree that the awarded scope of protection should be "commensurate" with the disclosed and sufficiently enabled contribution to the art, the contribution that we (as a person skilled in the art) can discover in the patent application as filed?

In the Decision, para 15 recites para 0005 of the specification. That para goes on about toxicity reductions using an anti-folate (of which one specific example is di-sodium pemetrexed) in combination with B12. That (anti-folate + B12) looks like a valuable contribution to the art. I'm not skilled in the art but the judge was better placed than me because he duly "donned the mantle", didn't he?

I suppose that the SC is striving to award the patent owner a scope commensurate with that contribution.

Engineering contributions are different of course because one can better predict what will work. But in common with pharma, your engineering competitor will come up with constructions you never envisaged and your tech people will shout loudly that it is an infringement nevertheless. They would be right too, wouldn't they?

Of course, it will be said that the attorney who limited the claim to di-sodium should have known better, and ensured that it would at least reach as far as di-potassium. But given the established law on EPC Art 54, 56, 83, 84 and 123(2) I think that is somewhat unfair. And the SC was trying to be fair.

Any more thoughts on that, pray?

Tim Jackson said...

To Observer:

The proprietor got protection for something that achieved substantially the same result in substantially the same way as what he contributed. Isn't that consistent with the Protocol's new Article 2 requirement to protect equivalents?

Perhaps your issue rests on the court's third question: would the skilled reader have concluded that the patentee intended that strict compliance with the literal meaning of the claim was an essential requirement of the invention? To you, the answer must be yes: he said 'disodium' and that was all he had tested, so disodium must be what he meant. Indeed, that was how the Court of Appeal saw it (see paragraph 70 of the Supreme Court's judgment).

However, I think that the Supreme Court was conscious that that approach could never cover equivalents lying outside the literal meaning of the claim. "... [I]f it was a decisive point it would make a nonsense of asking the three questions: if one cannot depart from the language of the claim when considering those questions, what is the point of the questions in the first place?" (paragraph 71).

That's not to say that the answer to the third question must always be 'no'. Clearly there will be cases where strict compliance with the literal meaning will be required. As to why the present case wasn't one of them, see paragraphs 72-75.


More generally, the reason the patentee didn't claim anything more than pemetrexed disodium was because their experiments had been performed on pemetrexed disodium, and the Examiner objected to the broader term 'pemetrexed' under Article 123(2), apparently as an intermediate generalisation from 'anti-folate' (paragraphs 78-80 of the decision).

That's a pretty standard EPO objection, but in paragraph 89 the Supreme Court expressed doubt about it. "It is unnecessary to decide the issue, but, at least as at present advised, I am inclined to think that the examiner was wrong in taking that view."

Unfortunately we can only speculate why the court felt that. However, they had a lot more evidence than the EPO examiner about the common general knowledge of the skilled person in this field, so maybe they were in a better position to judge what that person would have derived directly and unambiguously.

In particular, in paragraph 7 the court said one might have thought that "the actual invention should have been characterised as a disclosure that pemetrexed could be administered safely if it was combined in a medicament with vitamin B12", going on to explain why it was drafted in Swiss form instead. Note 'pemetrexed' generally, not just 'disodium'.

And in paragraphs 15-16, they quote passages of the description which refer to the use of vitamin B12 etc in combination with antifolates 'as a class'. Maybe we can speculate that the court believed that a skilled person would derive from his general knowledge that pemetrexed generally was a member of that class, to which the invention applied?

This does of course bring into question the EPO's strict application of Article 123(2), for which they are regularly criticised. Do they take an unduly narrow view of the extent to which an intelligent and knowledgeable skilled person is capable of deriving information from an application as originally filed?

PerplexedOfTunbridgeWells said...

I have mulled, and have now come to terms with the fact that scope for infringement and scope for validity are not necessarily commensurate. I am not perticularly welcoming to this approach, however, as it now seems that British litigation too will be host to Prof. Fransozi's famous cat.

I wonder also whether this type of decision will be used to justify the EPO's strict application of the Gold Standard, the rationale being that, since the Courts will broaden a claim if needed to take due account of equivalents in view of the overall interests of justice as between patentee and the public, it is even more important to ensure that the claims as written are limited to exactly that which has been unambiguously disclosed. This would then avoid the mischief that a Court might construe the claim, having been amended during grant proceedings to include equivalents by means of an impermissible intermediate generalisation, to include equivalents to equivalents to that which was disclosed (two-step equivalence).

But regardless of the theoreticals, I really do feel that this decision reduces legal certainty for parties in an IP dispute, since alleged infringer I will have a less clear picture of the scope of patentee P's claims, and maybe now as a matter of course must read not only the description but also the prosecution history (possibly in French or German) to understand the scope of protection that the Court might allow to the granted English claims. More work for litigators and opinion-writers, hey?

Proof of the pudding said...

Tim - you refer to the possibility of supplementary evidence supporting the presence of an inventive step. But of course the EPO only allows this where there is another reason for finding the invention (covered by the additional claim scope) "plausible" in the first place.

I can think of perfectly good arguments why using different (acid or salt) forms of pemetrexed would be made "plausible" by data demonstrating efficacy for the disodium salt. However, it does not matter what I think, the court really ought to have taken expert evidence on that point. And, to think about it, they also ought to have considered plausibility in the context of sufficiency of disclosure. After all, the claim was in "Swiss" format, and so the fact that efficacy in the treatment is a technical limitation of the claim could create a higher evidentiary hurdle for sufficiency of disclosure.

The point here is that the court extended the scope of protection to an area of claim scope that had only received cursory attention (under Article 123(2) EPC) during examination. Thus, there really ought to have been a lot more attention paid to the question of whether the patent could validly cover that subject matter.

Now, I have previously indicated that I have some sympathy with the point that Article 123(2) EPC need not be considered when assessing validity for the "additional" claim scope provided by equivalents. However, novelty, inventive step and sufficiency of disclosure all form the foundations of the patent monopoly (ie the patentee's side of the bargain with the public). Thus, I would expect courts to scrutinise those grounds very carefully in connection with purported equivalents before extending the scope of protection under Article 2 of the Protocol. I may have missed something, but I really do not see anything in the way of a validity assessment in the SC's judgement.

To hammer home my point about the problems with extending protection to unexamined subject matter, let us consider a hypothetical scenario. The scenario that I would like you to consider is one in which - despite some broad disclosures in the description relating to the treatment of pain (in general) - the indication in the claims of Warner-Lambert's patent was limited to "the treatment of peripheral neuropathic pain" only. In this scenario, the EPO "forced" the limitation under Article 123(2) and did not consider the patentability of claims extending to any other indications.

In that hypothetical scenario, would you think it a "fair" result if the extent of protection provided by Warner-Lambert's claims covered other indications, such as any type of neuropathic pain? And in that scenario, would a court considering only an application for a DNI bother checking whether sufficiency of disclosure was satisfied for other types of neuropathic pain, given that they just seem to be a "variation on a theme" and given that the (post-filing) evidence shows that the treatments work (in the same way as the rest of the invention)? As we all know too well, however, if validity is considered in great depth, there is (at least arguably) a sufficiency issue.

MaxDrei said...

Tim Jackson's post set me thinking.

I remember a childhood ditty about the loss of a horseshoe nail resulting in the loss of a Kingdom. It's like that here, isn't it. The absence of one sentence in the application as filed (the missing "intermediate generalization") resulted in the loss of a Kingdom. That is, until The Lord Neuberger intervened.

What is it about the EPO and added matter? It has got to the stage now where Applicant bears the burden of proving to the ED that the sought-for amendment does not add matter. It might be bad in pharma. I think it's worse for Applicant in engineering cases.

I explain it like this: Imagine you are serving as a Patent Office Examiner at the Spanish or Italian national Patent Office. You have some Spanish (or Italian) but not that of a native speaker. Applicant amends, using new wording, and assures you, hand on heart, that there is no new matter. Do you trust him? Wouldn't you rather see verbatim basis in the application as filed? You see, the EPO is the only Patent Office in the world that uses Examiners without first language English to examine cases written in English. And for up to 38 countries and 600 million people. No wonder they are cautious, pernickety, on added matter

I remember when the EPO was new and many people were Leary of filing there, committing all their precious eggs to one "basket". Here is a case where one missing sentence in the application as filed nearly had calamitous consequences for the Applicant (and the poor drafter).

Observer said...

To Tim Jackson,

I maintain my opinion that the examiner was correct and applied the standard practice of the EPO in the matter. I think the court was wrong to say that the examiner was wrong, as it brings in a lot of uncertainty into the system.

It is moot to try to figure out why the court did so, and we should not stick on this point. But an examiner cannot be blamed for having acted like that, the more so, since the applicant/proprietor did not make a single effort in attempting to overcome the objection. He was free to file further experimental data to support the broad allegations made. This data could not have been added to the specification, but a mention STIN (Supplementary Technical Information) could have figured on the front page of the patent. This is not uncommon in the field of pharmacy/biotech, be it for sufficiency, novelty or inventive step.

Disregarding the prosecution file is also difficult to understand. The only example given in the application was premetrexed disodium. The then applicant decided on its own volition only to pursue claims only based on premetrexed disodium. He never envisaged anything else. The mere fact that, although he only accepted to limit the claim to quickly obtain its patent, he never pursued the matter by filing a divisional on broader claims. Why should he then more than 10 years later obtain protection for something he never envisaged himself? To me file history should have played a role in the present case.

The whole introductory part is very vague when it comes to the anti-folates + vitamin B12. There is no support whatsoever for all the allegations made there. To me it is typical of what a representative should do: take an example and try to generalise it as much as possible.

Why should the applicant/proprietor benefit in hindsight for something he has not invented. His contribution to the art is limited to permetrexed sodium, and that’s it.

I would not say like one blogger said that the proprietor benefited from crappy drafting, on the contrary, he benefited from the uncertainties he had put in his own application. And that is to me also unfair.

It is even more unfair, as the SC not only ruled for the UK, but also for other countries on the basis of a DoE which has no basis in the EPC. Here is another unfair benefit for the proprietor.

Validity should by no means be confused with infringement, and it is good to know that equivalents belong to inventive step, and if not directly and unambiguously disclosed in the application as filed, they cannot be added later on. I hope the Boards of Appeal of the EPO will maintain their stiff stance in the matter. But what if tomorrow the UPC decides differently? Then the mess is guaranteed.

The practical implications of the decision are difficult to oversee, but they can have a deleterious effect on the whole patenting system. That is was is unsettling.

I think as far as I am concerned the discussion is exhausted, and unless there is an new important point coming up, I will then play Observer in the full meaning of the word.

MaxDrei said...

I have now seen the comments from Perplexed and Pudding but am not as pessimistic as they are.

With the separation in the EPO of search and examination, stuff gets searched (here: pemetrexed + B12) which is wider than the claim that goes to issue. The ED takes into account the results of the search.

Am sceptical that the EPO file wrapper is henceforth integral to claim construction. The SC construed on the basis of the Applicant's statements of invention in the specification, didn't it?

As to Pudding's hypo, that reminds me of US jurisprudence on "recapture" of scope explicitly discarded during prosecution to establish priority over the art. Until convinced to the contrary, I will continue to be optimistic that courts in Europe will also be steadfast in stopping a patent owner from recapturing scope which the Applicant ditched in order to achieve patentability over the art.

Proof of the pudding said...

Max - you can remain as optimistic as you like, but I am afraid the ship has already sailed in the Actavis v Eli Lilly case. The SC really should have considered validity (in depth) before extending claim scope to unexamined equivalents... but they failed to do so.

Now, perhaps you might say that this is a first example of "bifurcation" in the UK courts (it was a DNI action after all, and not a revocation) and/or that Actavis could or should have raised invalidity issues for any subject matter that it feared might be deemed an "equivalent". But any such arguments just don't hold any water. I mean, who amongst us ever foresaw the doctrine of equivalents coming to the UK, especially after Amgen v TKT? Also, other than discussing the added matter point, the SC simply omitted to give any serious consideration to validity of the "equivalents".

It seems that the best that we can do is hope for more "joined up" (infringement and validity) thinking in future DNI cases.

Of course, it is still open to Actavis to file a revocation action. That could prove very interesting indeed....

Tim Jackson said...

I appreciate that Tunbridge has come to terms with the fact that scope for infringement and scope for validity are not necessarily commensurate. I think we agree that it's important that they shouldn't overlap, but there can be a gap between them. The doctrine of equivalents is about the size and shape of that gap, but limiting it to the inventive concept prevents any overlap.

Tunbridge also raises Prof. Fransozi's Angora cat - a claim which is construed with a broad scope when attacking infringement but a narrow scope when defending validity. This is primarily of concern in a country like Germany, where infringement and validity are bifurcated and decided in separate courts. We are told that the German solution is the Formstein defence: that the scope of equivalents for infringement cannot extend to embodiments that would be invalid.

In England, the courts normally hear infringement and validity together, making it rather difficult to construe a claim differently like an Angora cat. And I've already pointed out that the present Supreme Court decision limits the scope of equivalents to embodiments that would be inventive.

That leaves cases where there is no claim for revocation (as indeed there wasn't in the present case). However, in the present case everyone seemed to accept that combining vitamin B12 with the other pemetrexed salts (or with the free acid) would have been novel and non-obvious. The reason we have an adversarial court system is so that Actavis could challenge on such grounds, but apparently they didn't. And the EPO examiner's initial search presumably covered that and more besides (since the originally-filed claims were much broader). The examiner could have objected to the pemetrexed claims for lack of novelty or obviousness, or indeed insufficiency, but those weren't the reason why he required the claims to be limited to the disodium salt.

In future cases where there is no claim for revocation, I think we will see defendants and potential infringers being quick to raise Gillette defences as soon as the patentee argues for a scope of equivalents that might not be inventive.


Proof of the Pudding argues that plausibility and sufficiency should be part of the consideration. I don't see why defendants and potential infringers can't raise it (though whether plausibility is the correct test for sufficiency remains to be seen -- it is the subject of the Warner Lambert appeal to the Supreme Court).

I see no reason to believe that the EPO would have failed to consider patentability and sufficiency in Pudding's hypothetical scenario based on Warner Lambert. My experience is that if multiple objections exist, they raise all of them. But even if they didn't, why is that relevant in an adversarial procedure where the defendant or potential infringer is free to raise it?


Observer remarks that the examiner was correct and applied the standard practice of the EPO under Article 123(2). But is the EPO's standard practice correct? It is certainly widely criticised.

Proof of the pudding said...

"I see no reason to believe that the EPO would have failed to consider patentability and sufficiency in Pudding's hypothetical scenario based on Warner Lambert. My experience is that if multiple objections exist, they raise all of them. But even if they didn't, why is that relevant in an adversarial procedure where the defendant or potential infringer is free to raise it?"

Tim, if you have never seen an EPO examiner raise only Art. 123(2) EPC objections and then refuse to do anything further (for the affected claims) until those have been addressed, then you have indeed lived a charmed existence. That kind of approach is all too common in my experience.

However, I find it interesting that the SC focussed only upon the Art. 123(2) objection that was raised by the EPO. This is because the examiner raised numerous other objections that were (at least potentially) relevant to the subject matter that the SC deemed "equivalent" to the claimed invention. In addition to Article 83 objections, the examiner alleged a lack of inventive step for all but claims 10, 12, 15, 17 (ie claims in which the antifolate was "ALIMTA"):
"The attention of the applicant is also drawn to the fact that all embodiments covered by the claims should satisfy the criteria of inventive step. When the inventive step is solely based on the achievement of a technical effect, such as "protection from antifolate toxicity" in the present case, substantially all embodiments (i.e. any combination of antifolate drug with a "methylmalonic acid lowering agent" and optionally a "FBP binding agent") should exhibit this effect.

However, it is evident that the number of possible combinations of the three components mentioned is such that it is unlikely that all of them inhibit the toxicity of the antifolate drug in a patient. Therefore, as part of the subject matter of claims 1-9, 11, 13, 14, 16 does not exhibit this particular technical effect in a credible manner, said subject matter cannot involve inventive step (see Decision of the Board of Appeal T939/92)
".

The Opposition Division also referred directly to evidence of efficacy (for the claimed treatment) as being key to the recognition of the presence of an inventive step.

Against this background, why is it that the SC did not (of its own volition) also consider Articles 54, 56 and 83 in connection with the alleged "equivalents"? Why pick on just Article 123(2) EPC?

The answer may well be that Actavis only relied upon the prosecution history for an estoppel point and not for a "squeeze" argument. But if the SC was intent on introducing a completely new way to interpret claim scope in the UK for infringement, and regardless of whether Actavis raised the point, ought they not have taken more care about extending claim scope to arguably invalid subject matter?

In this regard, my problem with the SC's decision to extend coverage to "equivalents" is not that I think it is impossible to do this in a sensible manner. Rather, my problem is that the SC failed to adopt a balanced and sensible approach in the case before them. In other words, regardless of whether the "equivalents" indeed represent a valid extension of the patents claim scope, the SC set a rather bad example by failing to give consideration to all relevant validity grounds.

Whilst others may be confident that the lower courts will do a better job in joining up validity and infringement, I take a more realistic approach. That is, whilst I am hopeful that sense will prevail, I am also fearful that such a bad precedent will lead to more decisions where there is either explicit or "hidden" asymmetry between the assessments of infringement and validity.

Proof of the pudding said...

I shall try again, as my comment from yesterday does not seem to have made it through.

"I see no reason to believe that the EPO would have failed to consider patentability and sufficiency in Pudding's hypothetical scenario based on Warner Lambert. My experience is that if multiple objections exist, they raise all of them. But even if they didn't, why is that relevant in an adversarial procedure where the defendant or potential infringer is free to raise it?"

Tim, if you have never seen an EPO examiner raise only Art. 123(2) EPC objections and then refuse to do anything further (for the affected claims) until those have been addressed, then you have indeed lived a charmed existence. That kind of approach is all too common in my experience.

However, I find it interesting that the SC focussed only upon the Art. 123(2) objection that was raised by the EPO. This is because the examiner raised numerous other objections that were (at least potentially) relevant to the subject matter that the SC deemed "equivalent" to the claimed invention. In addition to Article 83 objections, the examiner alleged a lack of inventive step for all but claims 10, 12, 15, 17 (ie claims in which the antifolate was "ALIMTA"):
"The attention of the applicant is also drawn to the fact that all embodiments covered by the claims should satisfy the criteria of inventive step. When the inventive step is solely based on the achievement of a technical effect, such as "protection from antifolate toxicity" in the present case, substantially all embodiments (i.e. any combination of antifolate drug with a "methylmalonic acid lowering agent" and optionally a "FBP binding agent") should exhibit this effect.

However, it is evident that the number of possible combinations of the three components mentioned is such that it is unlikely that all of them inhibit the toxicity of the antifolate drug in a patient. Therefore, as part of the subject matter of claims 1-9, 11, 13, 14, 16 does not exhibit this particular technical effect in a credible manner, said subject matter cannot involve inventive step (see Decision of the Board of Appeal T939/92)
".

The Opposition Division also referred directly to evidence of efficacy (for the claimed treatment) as being key to the recognition of the presence of an inventive step.

Against this background, why is it that the SC did not (of its own volition) also consider Articles 54, 56 and 83 in connection with the alleged "equivalents"? Why pick on just Article 123(2) EPC?

The answer may well be that Actavis only relied upon the prosecution history for an estoppel point and not for a "squeeze" argument. But if the SC was intent on introducing a completely new way to interpret claim scope in the UK for infringement, and regardless of whether Actavis raised the point, ought they not have taken more care about extending claim scope to arguably invalid subject matter?

In this regard, my problem with the SC's decision to extend coverage to "equivalents" is not that I think it is impossible to do this in a sensible manner. Rather, my problem is that the SC failed to adopt a balanced and sensible approach in the case before them. In other words, regardless of whether the "equivalents" indeed represent a valid extension of the patents claim scope, the SC set a rather bad example by failing to give consideration to all relevant validity grounds.

Whilst others may be confident that the lower courts will do a better job in joining up validity and infringement, I take a more realistic approach. That is, whilst I am hopeful that sense will prevail, I am also fearful that such a bad precedent will lead to more decisions where there is either explicit or "hidden" asymmetry between the assessments of infringement and validity.

Kant said...

Proof - that seems somewhat harsh. My reading is that the added subject matter and inventiveness issues are very closely linked. In order to show an inventive combination, you need to show efficacy (which was demonstrated only for ALIMTA, the sodium premetrexed) and for added subject matter there was no disclosure of any premetrexed other than sodium so that had to be included in order to avoid an intermediate generalisation. Would a subsequent demonstration that the potassium compound also showed beneficial effects have swayed the examiner on the inventive step argument (assuming the A123(2) point had gone away)? If so, then the limitation to sodium for inventiveness would not have been needed.

Proof of the pudding said...

Kant - my point is not that the "equivalents" are definitely non-inventive. Rather, my complaint is that the SC simply did not consider any grounds of validity other than added matter.

As the Warner-Lambert case goes to show, it pays not to make too many glib assumptions as to which claim scope will be determined to be valid by the courts (after all relevant arguments and expert evidence have been considered). Thus, whilst I can certainly see why one might instinctively feel that the "equivalents" indeed represented a valid (ie sufficiently disclosed, novel and inventive) extension of the claim scope, I am troubled by the fact that no detailed consideration was given to this matter at all.

Tim Jackson said...

Proof, I think the SC did consider sufficiency under Article 83, though perhaps indirectly. In paragraph 61, it quoted Floyd LJ in the Court of Appeal: "predicting in advance whether any particular counter-ion would work was not possible". It would require testing.

But the SC continued: However, as mentioned in para 25(i) above, salt screening is a routine exercise in determining suitability, and as Floyd LJ said, "the chemist would be reasonably confident that he would come up with a substitute for the sodium counter-ion".


On this and on Articles 54 and 56, I think you haven't taken into account the difference between how litigation works in common law jurisdictions, compared to civil law jurisdictions on continental Europe.

Courts in civil law countries may sometimes act inquisitorially of their own volition, and might therefore make some kind of investigation such as you seek. (Though even then I think it could be limited.)

But common law courts usually work on the adversarial principle, that the parties themselves are in a better position to bring forward the necessary facts and arguments.

Actavis chose not to raise the issues you are concerned about, so the court didn't have any reason to consider them. It didn't even focus on Article 123(2) as you suggest -- it said that it was "unnecessary to decide the issue" (paragraph 89).

So why did Actavis choose not to raise your issues?

Possibly because it was blindingly obvious that the free acid and the salts they were interested in were efficacious -- otherwise they wouldn't have been interested. So they would have lost if they attacked on inventiveness. And sufficiency had been considered as noted above.

The other, more direct reason was no doubt because they had undertaken not to challenge validity. See [2012] EWHC 3316 (Pat), paragraph 29. They wanted the English court to give declarations of non-infringement in a number of other EU countries. The Brussels I Regulation prevents this if validity is challenged.

That was a tactical decision by Actavis, but they have to accept the consequences.

Proof of the pudding said...

Tim - I can agree that, because of the constraints imposed by the manner in which Actavis ran their DNI case, they were unable to challenge validity for the "equivalents".

However, do you not think that there is an obvious (and slightly unsettling) conclusion that stems from this observation? That is, in future, it will impossible to run a "simple" DNI action - on the grounds that the applicant in a DNI action will always need to retain the option to allege invalidity for those "equivalents" that have not been (fully) examined pre-grant?

Remember, a simple "squeeze" argument will not work if the "equivalent" in question does not fall within the scope that the EPO will have examined. Indeed, it seems inevitable that UK case law will need to further evolve to address this point, which will always arise for equivalents that fall outside of the claim scope "as a matter of normal interpretation".

By the way, I don't agree that the SC (properly) considered sufficiency of disclosure, or that it was inevitable that the "equivalents" would be found to be inventive. Remember that this was a second medical use claim - and we all know how tricky "plausibility" can be in connection with such claims. Thus, I would say that validity for the "equivalents" is very far from being a foregone conclusion.

Tim Jackson said...

The constraints only apply if the DNI claimant wishes to include other EU countries under Brussels I. No such constraint applies to a normal English DNI.

Nor do I see any reason why a Gillette defence (or a squeeze) should be limited to the scope examined by the EPO.

Proof of the pudding said...

Tim - can you see a UK court, for the purposes of a DNI action, taking expert evidence on sufficiency and/or inventive step for certain embodiments alleged to fall within the extent of protection provided by second medical use claims?

I had always though that Gillette / "squeeze" arguments were allowed in DNI actions for the reason that they relate to patentability in the abstract for the allegedly infringing embodiments. That is, the validity analysis for such arguments does not consider the patent at all, except to use its priority or filing date as the time point at which to assess validity.

However, what happens if the alleged invalidity stems not from a "knock-out" disclosure (or combination of disclosures) in the prior art but instead from a problem with the disclosure of the patent?

Where the "disclosure" issue is added subject matter, we know that the SC's view is that the extent of protection can encompass the not (clearly and unambiguously) disclosed embodiment. But what if the "disclosure" issue relates to the absence of any data rendering it plausible that the invention extends to the allegedly infringing embodiments?

Whilst we can perhaps wait for the SC to opine upon plausibility in the context of sufficiency of disclosure, we do know (eg from Prendergast’s Applications) that there is a validity problem if a patent claiming a second medical use encompasses embodiments that represent nothing more than pure speculation.

So how, without challenging the validity of the patent, does the DNI applicant persuade the court that the patent in question - due to a defect in the disclosure of that patent - would be invalid if it encompassed the allegedly infringing embodiments?

If the EPO has fully examined (and rejected as purely speculative) the embodiments in question, then the DNI applicant could perhaps rely upon prosecution history to support a "squeeze" argument. But what if we are dealing with "equivalents" falling within claim scope that never received any detailed attention from the EPO - or even that never fell within the scope of the claims "as a matter of normal interpretation". Under those circumstances, would the court not need to assess validity ab initio, potentially hearing long and detailed arguments and/or expert evidence?

Unless you are telling me that the SC's decision means that second medical use patents can now validly encompass embodiments that were, or would have been, rejected by the EPO on substantive grounds (eg sufficiency or inventive step) then I would suggest that the SC's decision marks the beginning of the end of "simple" DNI actions - or at least those for which plausibility might play a part.

Observer said...

To Tim Jackson,

You might not like the stance taken by the EPO with regard to Art 123(2), but it is there, and unless it is proved absolutely wrong, it should be kept at it is.

It is coherent and links multiple aspects like novelty, added subject-matter and validity of the priority. This is often forgotten. And it gives some certainty.

I can agree that claim interpretation can be different in prosecution and infringement, but how different? A bit, a lot? In any case it should be commensurate with the contribution to the art of the applicant. An in the present case it was quite limited.

The decision is opening a Pandora's box, and only to see the numerous comments, it has brought a lot of uncertainty in the business.

When reading some comments, I get the feeling that the SC has fallen for the prosecution tactics of the parties. But simply alleging that any salt would work, is going a bit too far, at least in my opinion.

I doubt very much that the TBA or the EPO will change its practice in the matter.

MaxDrei said...

Observer, a question. Why should DG3 change? I personally see no need. I see no conflict between this UK SC Decision and the EPO Gold Standard.

More than that: I put to you that this Decision pays homage to the Gold Standard.

Observer said...

Dear Max Drei,

I am not sure if you mean it really that the SC decision pays homage to the Gold Standard. I sense a bit of tong in cheek. I do not want to hurt your feelings, but I gíve you my gut feeling, as well as my apologies if such might be the case.

In my opinion, what has been decided by the SC goes again the Gold Standard as it offers protection for something which has not been directly and unambiguously disclosed in the original specification.

It is the uncertainty brought out by the SC decision which is worrying.

Observer said...

Plausibility has been the subject of many comments. Although the case is different, in decision T 488/16 the patent has been revoked, and the TBA made a thorough analysis of the plausibility question, and did not allow a very broad claim.

http://www.epo.org/law-practice/case-law-appeals/recent/t160488eu1.html

I cannot refrain from seeing some parallels with the permetrexed case.

What do you think?

MaxDrei said...

Observer, you wrote:

"the SC goes again the Gold Standard as it offers protection for something which has not been directly and unambiguously disclosed in the original specification."

I quarrel with your word "as".

The GS is part of the jurisprudence of disclosure, not scope of protection. There never was a time in modern patent law, with claims to define the scope of protection, when scope of protection was confined to nothing wider than that subject matter which is directly and unambiguously disclosed in the application as filed.

Observer said...

Dear Max Drei,

You will not be surprised that I maintain my opinion and the "as" is there for a reason.

Even if I can agree that the scope of protection might be different from disclosure. The scope of protection has to be commensurate with the contribution to the art, and here the GS applies as well. The applicant/proprietor should not become more that what was directly and unambiguously disclosed in the original disclosure. In the present case it was limited to permetrexed disodium. Any claim for another salt would not have been admitted, and rightly so.

I say this being fully aware of Art 69 and its protocol, especially Art 2, but even looking very carefully, I cannot see there a definition of what an equivalent might be.

This should not come to a surprise to you. It has been my stance all the way along.

MaxDrei said...

Well, readers, I think that just about wraps the discussion up, don't you?

Observer said...

Dear Max Drei,

I do not see the things a drastically as you do. The discussion is not finished.

Just another thought/question: could the decision of the SC bring us back in the time following the Snackfood (T 73/88) discussions?

If one follows the reasoning of the SC, could the priority application also cover other salts than permetrexed disodium?

I am curious to hear you and Tim Jackson on this.

Snackfood supported said...

Observer, thanks for bringing that up again. No one seemed interested when I mentioned it earlier.

I don't want to preempt MaxDrei and Tim Jackson, but I think this SC decision goes back to the Snackfood way of looking at claims (i.e. consisting of essential and non-essential features) and therefore there is a separate discussion to be had about whether priority should be assessed like that also, so that the non-essential features do not need to be disclosed in the priority document. That would apply to the literal scope as well as the equivalents scope.

At some point the UK may realise that Snackfood is more in line with the UK concept of inventions and we may return to that doctrine as we participate less in Europe.

MaxDrei said...

Dear Observer, No.

Whether a claim is entitled at the EPO onto Paris Convention priority is a matter of "same invention", what the priority document discloses, and the validity of the claim. Apply the Gold Standard. Forget Snackfoods.

Whether an accused embodiment infringes is an Art 69 EPC issue. Consider the jurisprudence, throughout EPC-land, on Art 69 and its Protocol.

You seem to be trying to bind the Gold Standard to Art 69 EPC. Your crusade is misconceived and not soundly based.

We've been through all this already. Really, the discussion is exhausted.

Proof of the pudding said...

Max - the discussion continues because, perhaps not surprisingly, many of us are struggling to come to terms with the gulf that has apparently opened up between infringement and validity for purported "equivalents" of a claimed invention.

Of course, "gaps" between infringement and validity are nothing new. I am thinking in particular of the UK court decisions relating to terfenadine (Merrel Dow v Baker Norton) and tomoxetine (Actavis v Lilly [2015] EWHC 3294 (Pat)). However, those "gaps" are tiny in comparison to potential gulfs opened up by the SC's decision. Thus, it is now incumbent upon the UK courts to establish a way of ensuring that (leaving aside Art. 123(2) issues) the extent of protection never encompasses equivalents that, if positively recited in a patent claim, would have invalidated that claim.

I doubt that the debate will die down significantly unless and until there is progress on that point.

Why did this happen? said...

One could look at the decision in terms of how Neuberger is affecting the balance between the courts and the legislators. A doctrine of equivalents has been created and is something that then requires management by the courts, making the courts increasingly specialist and removed from the original creators of legislation.

Just to quote from his wikipedia entry he has had controversial moments:

'In May 2010, Neuberger gave a controversial, ex tempore dissenting judgment that the trade union Unite had not complied with ballot rules under trade union legislation.[14] In July 2010 Neuberger ruled that peace protesters in Parliament Square who had camped out in Democracy Village should be evicted after the protesters lost an appeal.[15]

In May 2011, while commenting on super injunctions, he said that social media sites like Twitter were "totally out of control" and society should consider ways to bring such websites under control.'

It is interesting to note that Neuberger has previously been accused of 'overreach' in a decision:

'In their Judicial Power Project report, on Judging the Public Interest: The Rule of Law vs. the Rule of Courts, Professors Ekins and Forsyth demonstrate how Lord Neuberger’s approach in Evans misinterprets legislation by imposing on s 53 an artificially narrow reading that departs from the intention of parliament set out in the clear language of the statute and, in turn, undermines the veto power granted to ministers. By engaging in this type of overreach, Lord Neuberger compromises the very rule of law he purports to defend and oversees a transfer of the power to determine the public interest from the elected legislature and statutorily mandated executive to the judiciary. (Further commentary on Evans from a range of contributors can be found here.)
Ultimately, what Lord Neuberger overlooks is that the question of who should decide the public interest is settled by positive law and long-standing constitutional practice, which the courts cannot remake in service of a theory of the separation of powers that does not accord with our tradition. The question of how or if to revise this positive law is primarily one for decision by elected politicians, not for judges.'
[https://policyexchange.org.uk/who-should-decide-who-decides-the-public-interest/]

The present decision seems to fit into the pattern of 'overreach'.

Observer said...

At least we can agree that we disagree.

I am fully aware that Art 69 has not much to do with Art 87, but the uncertainty created by the decision of the SC is difficult to deny.

What is better for the patent system at large: clearly defined contributions to the art, or relying to undefined equivalents?

I have my reply, you have yours, and life is wonderful!

And now, for something completely different (copyright Monty Pithon)

John said...

In regards to the relationship between validity and infringement I think a lot can be learned from the US (which Europeans seemed loathed to do). There the Patent Office uses the broadest reasonable interpretation to assess validity, whilst the courts use a normal interpretation. That could me one way of dealing with the additional equivalents scope potentially being invalid.

Tim Jackson said...

@Proof of the Pudding - I agree that it is incumbent on the court to ensure that the extent of protection never encompasses equivalents that, if positively recited in a patent claim, would have invalidated that claim. The court's solution is to ensure that the extent of protection is limited to the inventive concept. It is of course incumbent on challengers to ensure that they provide the court with any relevant evidence that the inventive concept is restricted because a proposed equivalent is not inventive.

@Why did this happen? - The need for a doctrine of equivalents was created by legislation, not by the court. See Article 2 of the Protocol to Article 69 EPC, inserted by the EPC 2000. The Protocol provides some limited guidance as to how the court should apply this, but cannot provide a definite answer to each case that comes up. The court's revised Protocol questions attempt to provide further guidance.

MaxDrei said...

Meanwhile,the DoE juerisprudence of the USA continues to evolve. See the Patently-O blog, most recent item, Link below, which concludes with these words:

"The Problems: In general, this case highlights the difficulties with DOE Doctrine. By definition, DOE only comes into play when the claim terms literally (expressly?) exclude the accused activity.  At that point, a court is asked to focus in on the function-way-result similarities between the claimed invention and the accused activity — a question that usually goes to a jury.  However, the courts are empowered to short-circuit the process and rule-out DOE if the claims expressly exclude the accused infringing mechanism – seemingly making DOE impossible to ever prove. Sad."
https://patentlyo.com/patent/2017/08/impossibility-doctrine-equivalents.html

At a conference in Ulm, a leading English patent judge (RJ perhaps) began his speech with a reference to US law. "We can learn a lot from the Americans." he said. Gasps from the audience. "Watch carefully what they do, and then do not make the same mistake that they have made." Relieved laughter from the audience.

The way I see it, the DoE is there for special situations. In engineering it is already quite tough to construe using purposive construction. A DoE might in some cases render construction incrementally more nuanced but, hey, it's not that big a deal, is it?

 

Why did this happen? said...

Thanks Tim,

To slightly disagree with you, yes doctrine of equivalents was created by legislation, but it was pretty 'dormant' in the UK until this decision. The Protocol had not been enacted in any definite way, and we all assumed that it could be fairly safely ignored. As proof of that I would refer to the surprise/shock by which this decision has been met. Things have changed a lot now, and that change is caused by the Courts. This is court-resurrected and I stick to my original assertion it is part of a Neuberger overreach phenomena (without saying whether that is good or bad)

John said...

MaxDrei

I think there is an argument to say DoE is dying in the US. This article says that, but is a bit dated itself:https://papers.ssrn.com/sol3/papers.cfm?abstract_id=956611

So I don't know whether the UK Supreme Court is ahead of the curve or behind the curve in comparison to the US in bringing back a DoE. Perhaps we need to go through having Doe to then decide in a few years that it was not helpful after all.

Tim Jackson said...

Why did this happen? said: "The Protocol had not been enacted in any definite way, and we all assumed that it could be fairly safely ignored."

I think the reason we ignored the emphasis on equivalents in the new Article 2 was because we assumed that the English courts would continue to say that purposive construction still did what was required. In fact, I can remember predicting exactly that at a seminar around the time that the EPC 2000 came into force.

And indeed, as a House of Lords decision, the lower courts continued to see Kirin-Amgen as binding, despite the fact that it dated from before the entry into force of the EPC 2000. It has taken until now for a case to reach the Supreme Court where it could be overturned.

Of course, the decision comes as a major shake-up, and it will take time for us all to come to terms with it. But I don't think you can call it judicial overreach for the SC to consider equivalents, when the legislation has been changed to say "due account shall be taken of any element which is equivalent to an element specified in the claims."

Why did this happen? said...

Thanks Tim

I don't think Judges Birss or Arnold would have issued a decision like this. Their decisions are very much circumscribed within the existing concepts of case law. It is difficult to predict of course exactly how they would behave as Supreme Court judges, but their decisions tend to be about small incremental changes to case law and they also seem to consider how people would react to their decisions, in terms of expected norms and the level of certainty which is required in the system. Neuberger is less constrained by these things. More of a free spirit.

Neuberger could have formulated a much tamer, less disruptive, doctrine of equivalents that would have taken into account the new wording, but not really changed much. I think he chose consciously not to in order to allow a new concept of what inventions are to take shape in the UK.

Kant said...

Referring to my post a long way above, Birss J. was more than happy to make a direct reference to the protocol in Ipcom.

MaxDrei said...

Not just Colin Birss but most everybody thought that purposive construction was enough to do justice and satisfy the Art 69 Protocol. It still is, in engineering cases.

But then along came a special case in chemistry. Special in many ways. A "perfect storm" ABC, if you will. Special enough to catalyze the creation of a DOE.

First and most important, the case was valuable enough to fight up to the wise old heads at the SC. Then:

A: The claimed molecule was limited to sodium and the infringer had the same molecule only with potassium. I learned at 12 years old how very similar K is to Na. It is the archetypal teaching example of a small increment of change. With my limited knowledge of higher chemistry, I cannot conceive of a smaller difference in between the molecule of the "accused embodiment" and the one the claim specified.

Why was the claim so narrow? Only because of B) a moment of carelessness in drafting the application, failing to include verbatim in the application as filed the vital intermediate generalization to cover BOTH of Na and K, AND C) the extreme strictness of intermediate generalization practice at the EPO.

As with Global Warming, the outlook in patent law is for more and heavier storms. But we are now better prepared for them, eh, with our newly minted DoE. I suspect Neuburger wanted to deliver a legacy, an Opinion exhibiting impeccable logic and beautifully readable, a law of claim construction that would serve as a blueprint and road map, not just for the UK but for patent jurists and academics all over the world. What I mean is, something as well-known and respected amongst patent jurists as the OED is, all round the world, amongst philologists and lexicographers.

I never tire of pointing out that patent law was fully harmonized in 1973 by the EPC. Germany negotiated its EPC terms on behalf of countries like Japan, Korea and China (who adopt, lock stock and barrel German patent law thinking), while the UK negotiated on behalf of English law countries everywhere. No further harmonization is needed. What a stupendous achievement for Europe.

And now, 40 years later, Neuburger finally shows us how to "do" infringement under the EPC, the same in every jurisdiction.

Anonymous said...

My foremost concern is that the court has, perhaps, made a distinction without a difference when it distinguished between interpreting the patent and delineating the scope of protection. The first sentence of art 1 EPO reads, 'Article 69 should not be interpreted as meaning that the extent of protection conferred by a European patent is to be understood as defined by...'. While the sentence goes on to dismiss a literal interpretation of a patent, it is not without significance because the third sentence cites it as wrongful extreme for construing a patent.

I believe that the first sentence of art 1 is also significant because, contrary to the court's view, it alludes to a causative relationship between interpreting a patent's language and defining the extent of protection. Although the sentence rebukes the literal approach to claim construction, it also implies that the process of interpreting a patent's language to define the extent of protection is the correct approach. What is important is that there is a balance between literalism and repudiating the importance of the patent claims entirely when a court undertakes this process.

John said...

I response to Anonymous of 4:57, I think you'll find that when it comes to secondary infringement we already have the situation where the infringement scope can be far removed from the literal claim language,
e.g. William Hill and where the invention is 'put into effect'
[http://www.mondaq.com/x/19051/Patent/William+Hill+Loses+Gamble+with+Internet+Patent]. If you have ever tried to delineate the scope of secondary infringement you'll see that is sometimes very difficult. So using literal scope as the starting point for looking at infringement is not a new concept.

MaxDrei - remember the UK is not a civil law country, and so we don't base our law on 'principles' as much as clear rules and boundaries. The claim is not a reflection of the inventive concept, but much more a boundary. I like your legacy and roadmap comments, but I suppose am slightly perturbed as to where this road is going.

MaxDrei said...

Thank you John for your kind remarks, but I feel I must pick you up on one thing you write, namely: "The claim is............a boundary".

For years I have invited clients outside Europe to think of the two extremes of the Art 69 Protocol as follows. The Olde English (peripheral claiming) way is using a claim to define the edge of the golf green. The ball is either on the green or it ain't.

The Olde German (central claiming) way is to view the claim as the flag delineating the hole, which is somewhere near the middle of the green, where the "best mode" or "most preferred embodiment" lies. Find in the claim a definition of at least the Best Mode, as the point of origin of your imagined crop circle and of the judge's task of fixing the scope of protection you are going to be given.

Here, we have di-sodium as the best mode and a claim that flags it up. Judge Neuberger's task was to decide how big to make the green surrounding the hole. He has to ask himself: is di-potassium on the green or in the rough?

And while we are mulling over that question, by the way, doesn't the Protocol forbid thinking of the claim any longer as a clear-cut, trim edge "boundary"?

I take your point about principle and precedent. But if you compare the USA's "abstract" test with the EPO's "technical" test, which jurisdiction makes a better job of fixing a boundary with legal certainty? Is it the Binding Precedent of an English law Supreme Court or is it the civil law Darwinian evolution of the definition of "technical" as practised by the EPO's EBA?

Sometimes a bit of short term uncertainty (as here) is the price to be paid for keeping the overall direction of the evolving caselaw moving in the right direction.

Or what do you say?

John said...

Thanks MaxDrei. I agree with the notion of allowing the case law to evolve. Some of the arguments against having a specialist patent appeal court in the US are that it would allow other case law doctrines to evolve if more than one court was involved, and ultimately that makes case law richer and more dynamic, but also of increase uncertainty. There will be directions that are ultimately found to be unhelpful and so case law then has to change direction, etc.

However in terms of what a claim is, I don't think it can be said to be the same as the 'technical effect'. Sometimes applicants will want to voluntarily limit their claim scope (for example due to an agreement with another party), or to minimise the chance of an opposition happening (I have been in that situation). And so the literal scope is important as a sign of what the applicant chose to pursue at that time (and chose to limit to in examination). I therefore think that whilst the technical effect is an important component in determining claim scope it cannot be only one. And I agree that the system needs to be thrown into this new uncertainty to decide whether we want to think in terms of a 'flag', and whether a usable test based on that can emerge. [People of course do not like uncertainty and so this will be a painful journey]

I think the 'abstract idea' test in the US is interesting because the Supreme Court has chosen to say little about it, and it is being allowed evolve at the hands of the Federal Circuit, where it will I am sure end up being the same as a 'technical effect' test. You will be familiar with the level of criticism that that test has encountered, but I think it is a great experiment. The Supreme Court had the wisdom to be minimalist about it, and let it evolve, realising the test was too complex to be derived by simply thinking of one. A test will come into being which is found to be useful in the cases that the Federal Circuit has before it.

MaxDrei said...

John I agree with you on "abstract" and I agree that fixing the scope of protection is not the same as identifying the technical effect. I like the Neuberger evolved version of the Catnic Questions.

Courts need a residual degree of wiggle room to do justice. Neuberger gives them just enough, but no more than that. Like the EPO's Problem and Solution for framing the obviousness debate, the Neuberger 3 Question rubric gives the parties a framework for efficient debate on scope of protection.

In my view, the evolved Three Question routine represents an optimal compromise between fair protection for the patent owner and reasonable legal certainty for those under threat from the patent.

Proof of the pudding said...

Apart from the issue regarding untested validity, there is another problem with "stretching" the extent of protection to encompass "equivalents".

The courts only ever need to answer the question of whether a very specific embodiment (or at most a handful of very specific embodiments) represents an "equivalent" of the claimed invention. However, third parties and patent offices do not have the luxury of only considering such a small number of precisely defined, putative "equivalents".

For patent offices, it is essentially impossible to assess validity for all "equivalents" of a claimed invention. This is because it is impossible to predict in advance which embodiments falling outside of the literal claim scope might, with the benefit of hindsight, prove to be "immaterial variants" of the claimed invention.

Third parties face the same problem, with the consequence that those seeking to "design around" the claims of a patent will face far greater uncertainty regarding freedom to operate for far longer than is currently the case. This will clearly have a chilling effect on competition.

Is this the patent system that we all want? Don't get me wrong, I am all for providing patentees with a fair reward for disclosure of their invention. However, my view is that the importance of providing that reward needs to be balanced against the importance of ensuring a reasonable degree of certainty for third parties.

The SC's decision affords protection to "equivalents" that can only be identified as such after their creation, and that represent embodiments of the invention that are highly unlikely to have been properly assessed for validity pre-grant. This surely cannot be right, especially in a jurisdiction that is supposed to assess validity and infringement together. On this ground, I think that the SC's decision will need some "vigorous re-tuning" before it truly becomes fit for purpose.

John said...

Proof of the Pudding that is a very good point. 'Immaterial variants' could also change status to become 'material' as prior art is discovered after grant and the problem that is solved changes.

I agree with you that Patent Offices cannot be expected to factor 'equivalents' into examination, and so we are left with a situation where the claim scope only gets precisely defined once a possible infringement is identified.

We'll never know Neuberger's inner thoughts about this. Perhaps he feels not enough licencing is happening or that patent litigation is too costly and expensive and this is his way of forcing parties to talk to each other or pave the way for compulsory cross-licensing to come into being. He could never say such things in public as his prestigious position also hamstrings him in what he can say, even though he would be highly qualified to have opinions such as these. Neuberger will have his own opinions on how best the system is served by the patent system or the courts, and this parting shot before he retires might be the radical step that he believes is needed to trigger 'vigorous re-tuning' of the whole system. I don't know

MaxDrei said...

Agreed. But it is not as if this SC Decision introduced uncertainty as to scope where there was none before. Those giving clearance opinions have always had to take account of the Art 69 Protocol. Caselaw evolves but the Protocol endures. Clearance opinions have always had to take into account how the caselaw will evolve during the life of the patent in view, to reflect the Protocol. In practice. how much more vague will they be, as a result of this Decision? A great deal, not much, or hardly at all?

Observer said...

It will not come as a surprise that I cannot agree with Max Drei. The decision of the SC is in no way " an optimal compromise between fair protection for the patent owner and reasonable legal certainty for those under threat from the patent".

I am however fully agreeing with Proof of Pudding. What is indeed disturbing is that after grant, the SC put something under protection which had never been envisaged by the applicant/proprietor who deliberately accepted a limited claim.

And that Lord Neuberger found that on the basis of what was available to the ED during prosecution it acted incorrectly is going a trifle too far.

Re-tuning of the decision is to be hoped, or at least a decision which is not as borderline as the present one.

Proof of the pudding said...

It is the hindsight part of Neuberger's analysis that creates the most uncertainty. Thus, my suggestion for "re-tuning" the decision would be to re-write Neuberger's question 2 as follows:
"Would the person skilled in the art, reading the patent at the priority date, find it plausible that the variant achieves substantially the same result as the invention and that it does so in substantially the same way as the invention?".

This would bring the decision much more into line with the EPO's approach to assessing validity (eg as in Johns Hopkins). It would also help to afford third parties a more reasonable degree of certainty. This is because it might at least allow an assessment of freedom to operate to be conducted at the point when "variants" are first conceived, as opposed to only after they have been made and tested. Whilst that might not keep up-front FTO costs down at the level they were prior to the SC's decision, it would not have as much of a chilling effect on competition as the SC's current version of question 2.

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